Agency classClass IIOur severity:High FDA (Devices)·Z-2602-2023·Announced 2023-09-27

Stryker ACM System nozzle may disassemble during bone cement mixing

The break-away femoral nozzle in Stryker's ACM System may disassemble during use, potentially leaving fragments in the surgical site and causing device failure.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device with potential for equipment failure and foreign material in surgical site, but no reported illnesses or injuries. The hazard is stated as potential/theoretical risk, fitting the 'High' category: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Corporation has recalled the ACM (Advanced Cement Mixing) System, a device used during orthopedic joint surgery to mix bone cement with consistent high vacuum. The recall focuses on kits containing the femoral break-away nozzle (applicator tip) that connects the cement cartridge to the mixing system. The affected lot numbers are 22306012, 22307012, 22340012, 22341012, 22342012, and 23017012.

The break-away femoral nozzle may disassemble or break off during use. If this occurs, fragments could fall into the surgical site, potentially causing loss of function of the ACM system and introducing foreign material that could compromise biocompatibility.

Approximately 231 units were distributed in the United States and 21 units internationally to Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Malaysia, Poland, Singapore, South Korea, Spain, Taiwan, Thailand, and the United Kingdom.

The FDA classified this as a Class II recall. Medical facilities and surgeons using this equipment should verify they do not have affected lot numbers in stock. Stryker has contacted affected customers directly. No illnesses or injuries have been reported.

The recalled product

Product: Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement with a constant high vacuum through the process. Catalog Number: 0306-705-000
Manufacturer: Stryker Corporation
Category: Medical Device — Orthopedic Surgical Equipment
Hazard: equipment-failure
foreign-body-risk

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Stryker Corporation

See all →

High
Stryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
High
Stryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
High
Stryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
High
Stryker Single Spike Tube Set Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
Severe
Stryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12

Same hazard · equipment failure